Package Inspection White Papers & Case Studies
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Non-Invasive Headspace Analysis For Automated Media Fill Microbial Inspection
12/28/2018
Laser-based headspace provides yet another alternative approach for detecting microbial contamination in sterile pharmaceutical product allows for quicker, more sensitive, accurate, and reproducible test results when compared with conventional, growth-based methods.
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Headspace Oxygen Monitoring On A Pre-filled Syringe Line Filling Oxygen-Sensitive Product
12/28/2018
This application note describes how laser-based headspace analysis is used for the rapid non-destructive determination of headspace oxygen levels in pre-filled syringes. Data is presented demonstrating two major applications of this technique: 1) headspace oxygen monitoring on a pre-filled syringe line filling oxygen-sensitive product, and 2) container closure testing of pre-filled syringes.
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Determination Of Moisture Permeation During Product Shelf Life
12/27/2018
How non-destructive headspace analysis information can be critical for QC groups performing stability studies, or for packaging development groups responsible for choosing the optimal packaging.
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Lyo Chamber Moisture Mapping
12/27/2018
Rapid non-destructive headspace moisture analysis from LIGHTHOUSE enables fast moisture determination of statistical numbers of lyo samples.
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Root Cause Investigation Into A Possible Container Closure Integrity Failure
12/27/2018
In cases where oxidation of the formulation causes discoloration and eventual degradation of the product, non-destructive headspace analysis tests can give deep insight into the root cause. Since the samples are not destroyed by the headspace analysis, further testing can be done to accurately correlate headspace conditions with other product characteristics.
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Sterile Production Process Studies Using 100% Headspace Inspection Of Finished Product
12/27/2018
This app note describes the application of the PULSAR inspection platform to perform 100% headspace oxygen monitoring during the filling of oxygen-sensitive formulations, 100% container closure inspection of suspect batches, moisture inspection of freeze dried product, and automated media fill inspection.
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Nitrogen Purge Optimization And Validation Of Sterile Liquid Filling Lines
12/27/2018
Large molecule biopharmaceuticals can be prone to oxidation and to prevent this from occurring, the headspace is often purged with an inert gas during filling to ensure a longer shelf life.
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In-Process Monitoring Of Headspace Oxygen Levels In Parenteral Containers
12/27/2018
Using a high sensitivity detection technique known as Frequency Modulation Spectroscopy (FMS), LIGHTHOUSE rapid non-destructive headspace oxygen inspection can help streamline the monitoring of purge performance on the filling line. This paper demonstrates the correlation of the FMS rapid non-destructive technique for analyzing headspace oxygen levels with the most commonly used conventional destructive techniques for headspace oxygen inspection.
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Implementing FDA Guidance: CCI Testing In Lieu Of Sterility Testing
12/26/2018
This application note details FDA released guidance titled “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products."
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Container Closure Integrity Of Sterile Vials During Deep Cold Storage
12/26/2018
Learn how rapid, nondestructive laser-based headspace analysis can support with data generation to demonstrate the maintenance of seal integrity during deep cold storage and transport.